benefitrisk

Benefit-risk, or benefit–risk assessment, is a framework for evaluating the positive outcomes of a proposed action against its potential harms. The approach is used across fields such as medicine, pharmacovigilance, public health, medical devices, environmental policy, and finance to inform decisions about approval, use, or adoption.

The core idea is to weigh benefits—such as efficacy, symptom relief, improved quality of life, or societal gains—against risks, including adverse events, costs, and potential harms. The relative value of benefits and risks depends on context: disease severity, population characteristics, time horizon, and stakeholder preferences. Decision makers consider both the magnitude and the probability of outcomes, as well as uncertainties and trade-offs.

Common methods combine qualitative judgments with quantitative tools. Quantitative approaches may calculate absolute risk reductions, numbers needed to treat or harm, risk ratios, and cost-effectiveness analyses using quality-adjusted life years (QALYs) or incremental cost-effectiveness ratios (ICERs). Multi-criteria decision analysis (MCDA) can integrate multiple outcomes with assigned weights. Sensitivity analyses test how results change with different assumptions.

Data sources include clinical trial results, observational studies, post-marketing surveillance, patient-reported outcomes, and economic data. The assessment typically follows steps: define decision objectives, identify benefits and risks, estimate magnitude and probability, compare alternatives or thresholds, and document uncertainties before making a recommendation or policy decision. In practice, benefit-risk assessments inform regulatory approvals, labeling decisions, risk-management plans, and broader policy choices.

Critics note challenges in quantifying effects, handling uncertainty, and incorporating equity and patient values. Properly conducted, the framework aims to support transparent, evidence-based decisions that reflect societal priorities.